DESCRIPTION: (From the applicant's abstract) It will soon be possible to test for a breast-ovarian cancer susceptibility gene (BRCA1) that accounts for approximately 5% of breast cancer cases. Because of anticipated high consumer and provider demand, primary care physicians and nurse practitioners will be called upon to offer presymptomatic counseling and testing. Little attention has been paid to the elements of informed consent that ought to be part of BRCA1 testing. The proposed study will develop, implement and evaluate a model informed consent process for genetic testing for breast cancer that integrates the perceptions of consumers and providers. The model informed consent process will address both content and style of disclosure and counseling. In four focus groups of local providers (32 nurse practitioners, genetic counselors and physicians from internal medicine, family practice, gynecology, and general surgery), we will explore scenarios that assess their expectations of informed consent for BRCA1 testing, and then develop a questionnaire that reflects their responses. By surveys of first (N=240) and third year (N=240) medical students, nurse practitioners (N=200), and physicians [residents (N=525) and non- residents (N=400) from the above specialties, we will assess knowledge of breast cancer genetics, expectations of what should be disclosed and how directively the test should be offered, risk perception and perceived role in obtaining informed consent, using scenarios that depict women of different races, risks and socio-economic status. We also will examine factors influencing providers' knowledge and expectations, including changes that might occur during the medical socialization process. Building on a previous grant in which focus groups of consumers discussed BRCA1 testing, we will develop and administer a consumer survey, paralleling the provider survey, that assesses their expectations of the informed consent process for BRCA1 testing. This survey will involve approximately 840 consumers, half of whom will be female and male first degree relatives of young affected women, and half will be women in the general population, ascertained through gynecologic and medical clinics at a local HMO. After examining discrepancies between and among groups of consumers and providers, we will establish model educational materials for the informed consent process that reflect the expectations of consumers and providers. We will implement a pilot BRCA1 testing program that incorporates the content of disclosure appropriate for each category of patient, and randomize 140 female and male patients who are eligible and interested in BRAC1 testing to one of two disclosure styles: individual or group pre-test education and counseling. We will evaluate both the content and style of our model informed consent process in terms of patient knowledge, satisfaction, perceived decision-making autonomy and testing decisions. Our findings will have implications for the offering and utilization of genetic testing for breast and ovarian cancer, and for the development of informed consent guidelines. The results also will point to necessary improvements in medical training with regard to offering and obtaining consent for predictive testing.